Reiterative Development and Evaluation Study of OSA Therapy System



Status:Completed
Conditions:Insomnia Sleep Studies, Pulmonary
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 80
Updated:4/2/2016
Start Date:July 2012
End Date:July 2014

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A Multicenter, Prospective, Variable Duration, Reiterative Development and Evaluation Study of ApniCure's Therapy System(s) for the Treatment of Obstructive Sleep Apnea (OSA)

The purpose of this study is to evaluate new iterations/generations of the ApniCure sleep
therapy device.


Inclusion Criteria:

1. Subject is between the ages of 18 and 80.

2. Subject is fluent in English and understands the Study protocol and is willing and
able to comply with Study requirements and sign the informed consent form.

3. Subject has a least one molar in each of the four quadrants of the mouth (right
upper, right lower, left upper, and left lower).

Exclusion Criteria:

1. Poor nasal patency as evidenced by the inability to breathe through the nose with the
mouth closed.

2. Oral cavity infection or any other oral or dental condition or problem that would
limit subject use of the ApniCure System (e.g. dentures, loose tooth/teeth,
temporomandibular joint (TMJ) conditions, or any oral or dental condition that the
Investigator believes could be exacerbated by the Attune Sleep Apnea System.

3. History of any OSA surgical treatment including uvulopalatopharyngoplasty surgery
(UPPP), maxillomandibular advancement surgery (MMA), radio frequency (RF) ablation
treatment, palatal stent devices, etc.

4. Any concomitant diagnosed or suspected sleep or chronic neurological disorders, other
than OSA, including insomnia, and central sleep apnea.

5. Currently working nights, or rotating night shifts.

6. Current disease state, use of medication or other treatment which, in the
investigator's opinion, may pose additional risk to the subject or confound the
results of the study.

7. Female subjects of child bearing age who are pregnant or intend to become pregnant
during the study period.
We found this trial at
7
sites
Columbia, South Carolina 29201
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Columbia, SC
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Atlanta, GA
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Burlingame, California 94010
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Burlingame, CA
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Chevy Chase, Maryland 20815
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Chevy Chase, MD
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Dallas, TX
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Louisville, Kentucky 40217
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Louisville, KY
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Redwood City, California 94063
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Redwood City, CA
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